Status:
RECRUITING
A Real-world Study of Camrelizumab Combined With Apatinib Mesylate in Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Collaborating Sponsors:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Brief Summary
To evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the treatment of unresectable hepatocellular carcinoma.
Detailed Description
Combination therapy for patients with unresectable liver cancer is the future trend, and with the development of therapeutic drugs for liver cancer, especially molecular targeted drugs and immunothera...
Eligibility Criteria
Inclusion
- Age: 18 years old ≤ age ≤ 75 years old, both male and female;
- Strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 Edition) or hepatocellular carcinoma patients diagnosed by histopathological or cytological examinations , and at least one measurable lesion (according to the mRECIST1.1 standard, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the malignant lymph node is ≥15mm);
- Not previously accepted Patients with hepatocellular carcinoma who have progressed/intolerable and unresectable after systemic therapy or first-line systemic therapy;
- CNLC stage IIb-IIIb;
- Child-Pugh liver function grade A or B (5- 7 points);
- ECOG PS score 0-1 points;
- Expected survival period ≥ 12 weeks;
- If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA ≤ 2000, you can start directly Treatment; if HBV-DNA\>2000, antiviral treatment should be given for one week before starting treatment;
- The subjects volunteered to join the study, had good compliance, and cooperated with follow-up.
Exclusion
- Pregnant or breastfeeding women;
- Patients with contraindications to immunotherapy, including but not limited to the following: post-transplantation patients, patients with severe autoimmune diseases, patients with organ failure, patients who have previously experienced adverse reactions of grade 4 or above using immunotherapy, and uncontrolled infectious diseases;
- Use immunosuppressive or systemic hormone therapy within 14 days before enrollment to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other equivalent hormones);
- It has been confirmed that camrelizumab Patients who are allergic to injections, apatinib mesylate tablets and their excipients, or are allergic to other monoclonal antibodies;
- Patients with impaired consciousness or inability to cooperate with treatment, combined with mental illness;
- Patients who have participated in other clinical trials in the past three months;
- Severe liver, kidney, heart, lung, brain and other major organ failure;
- According to the investigator's judgment, patients with other serious concomitant diseases that endanger the patient's safety or affect the patient's completion of the study.
Key Trial Info
Start Date :
August 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05409482
Start Date
August 20 2022
End Date
March 1 2026
Last Update
May 13 2025
Active Locations (1)
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1
Mengchao Hepatobiliary Hospital, Fujian Medical University
Fuzhou, Fujian, China